EVEROLIMUS 5 mg Tablet

Зміст інструкції

1. Everolimus medac 5 mg tablets, 10 mg tablets
   1. What is Everolimus medac and what is it used for
   2. What you need to know before taking Everolimus medac
   3. How to take Everolimus medac
   4. Possible side effects
   5. How to store Everolimus medac
   6. Contents of the pack and other information

Everolimus medac 5 mg tablets, 10 mg tablets

Everolimus

Generic medicine

Read this leaflet carefully before you start taking this medicine because it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

• 1. What Everolimus medac is and what it is used for
• 2. What you need to know before you take Everolimus medac
• 3. How to take Everolimus medac
• 4. Possible side effects
• 5. How to store Everolimus medac
• 6. Contents of the pack and other information

1. What is Everolimus medac and what is it used for

Everolimus medac is an anti-cancer medicine containing an active substance called everolimus.
Everolimus reduces the blood supply to the tumor and slows the growth and spread of cancer cells.
Everolimus medac is used to treat adult patients with:

• advanced breast cancer with positive hormone receptor status in postmenopausal women, in whom other treatments (defined as “non-steroidal aromatase inhibitors”) are no longer able to keep the disease under control. It is administered together with a type of medicine called exemestane, a steroidal aromatase inhibitor, which is used for anti-cancer hormonal therapy.
• advanced tumors called neuroendocrine tumors that originate from the stomach, intestine, lung or pancreas. It is used if the tumors are inoperable and do not overproduce specific hormones or other related natural substances
• advanced kidney cancer (advanced renal carcinoma) where other treatments (defined as “anti-VEGF targeted therapies”) have not been helpful in stopping the disease.

2. What you need to know before taking Everolimus medac

Everolimus medac will only be prescribed by a doctor experienced in the treatment of cancer. Follow
carefully all the doctor's instructions. These instructions may be different from the information
prescribed, consult your doctor.

Do not take Everolimus medac

• if you are allergicto everolimus, to similar substances such as sirolimus or temsirolimus, or to any of the other ingredients of this medicine (listed in section 6). If you think you may be allergic, ask your doctor for advice.

Warnings and precautions
Talk to your doctor before taking Everolimus medac:

• if you have liver problems or have had any illness that may have affected your liver. If this is the case, your doctor may need to prescribe a different dose of Everolimus medac.
• if you have diabetes (high blood sugar levels). Everolimus medac may increase blood sugar levels and worsen diabetes mellitus. This may require the use of insulin and/or oral antidiabetic agents. Tell your doctor if you experience excessive thirst or increased frequency of urination.
• if you need to get a vaccine while taking Everolimus medac.
• if you have high cholesterol levels. Everolimus medac may raise cholesterol and/or other fat levels in the blood.
• if you have recently had surgery, or if you have a wound that has not yet healed following surgery. Everolimus medac may increase the risk of problems related to wound healing.
• if you have an infection. It may be necessary to treat the infection before starting Everolimus medac.
• if you have previously had hepatitis B, because it may reactivate during treatment with Everolimus medac (see section 4 ‘Possible side effects’). Everolimus medac may also:
• weaken the immune system. Therefore, you may be at risk of contracting an infection during treatment with Everolimus medac.
• impair kidney function. Therefore, your doctor will check your kidney function during treatment with Everolimus medac.
• cause shortness of breath, cough and fever.

Tell your doctorif you experience these symptoms.
You will have regular blood tests during treatment. These tests will check the
amount of blood cells in your body (white blood cells, red blood cells and platelets) to see if
Everolimus medac has an undesirable effect on these cells. You will also have blood tests to
check kidney function (creatinine level) and liver function (transaminase levels)
and blood sugar and cholesterol levels. These levels can also be affected by
Everolimus medac.

Children and adolescents
Everolimus medac should not be used in children or adolescents (under 18 years of age).

Other medicines and Everolimus medac
Everolimus medac can affect the action of some medicines. If you are taking other medicines at the
same time as you are taking Everolimus medac, your doctor may need to adjust the
dose of Everolimus medac or the other medicines.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicine.
The following substances may increase the risk of side effects with Everolimus medac:

• ketoconazole, itraconazole, voriconazole, or fluconazole and other antifungals used to treat fungal infections.
• clarithromycin, telithromycin or erythromycin, antibiotics used to treat bacterial infections.
• ritonavir and other medicines used to treat HIV/AIDS infection.
• verapamil or diltiazem used to treat heart conditions or high blood pressure.
• dronedarone, used to help regulate the heartbeat.
• cyclosporine, a medicine used to prevent the body from rejecting transplanted organs.
• imatinib, used to block the growth of abnormal cells.
• angiotensin converting enzyme (ACE) inhibitors (such as ramipril) used to treat high blood pressure or other cardiovascular problems. The following substances may reduce the effectiveness of Everolimus medac:
• rifampicin, used to treat tuberculosis (TB).
• efavirenz or nevirapine, used to treat HIV/AIDS infection
• St John's wort ( Hypericum perforatum), a herbal product used to treat depression and other conditions.
• dexamethasone, a corticosteroid used to treat a wide range of conditions including inflammatory or immune problems.
• phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to block seizures.

These medicines should be avoided during treatment with Everolimus medac. If you are taking any
of these medicines, your doctor may prescribe different medicines, or may adjust your dose of
Everolimus medac.

Everolimus medac with food and drink
You should take Everolimus medac at the same time each day, regularly with or without food. Avoid
grapefruit and grapefruit juice while being treated with Everolimus medac.

Pregnancy, breastfeeding and fertility
If you are pregnant, if you suspect you are pregnant or if you are planning a pregnancy, or if you are breastfeeding, ask your doctor for advice before taking this medicine.
Pregnancy
Everolimus medac may harm the fetus and is not recommended during pregnancy. Tell your doctor
if you are pregnant or suspect you may be pregnant. Your doctor will discuss with you whether you should take this
medicine during pregnancy.
Women who could become pregnant must use highly effective contraception
during treatment. If, despite these measures, you suspect you are pregnant, ask your doctor
beforetaking Everolimus medac again.
Breastfeeding
Everolimus medac may harm the infant. You should not breastfeed during treatment. Tell your
doctor if you are breastfeeding.

Female fertility
Menstrual cycle irregularities (amenorrhea) have been observed in some patients treated with Everolimus medac.
Everolimus medac may have an impact on female fertility. Tell your doctor if you want to have children.

Male fertility
Everolimus medac may affect male fertility. Talk to your doctor if you want to become a father.

Driving and operating machinery
If you feel unusually tired (fatigue is a very common side effect), be particularly
careful when driving vehicles or using machinery.

Everolimus medac contains lactose
Everolimus medac contains lactose (milk sugar). If you have been diagnosed with intolerance to
some sugars, contact your doctor before taking this medicine.

3. How to take Everolimus medac

Take this medicine following exactly the instructions of your doctor or pharmacist. If you have
any doubts, ask your doctor or pharmacist.
The recommended dose is 10 mg, taken once a day. Your doctor will tell you how many tablets of
Everolimus medac you will need to take.
If you have liver problems, your doctor may prescribe a lower dose of Everolimus medac.
If certain side effects occur while you are taking Everolimus medac (see section 4), your
doctor may reduce your dose or interrupt treatment for a short period of time or permanently.
Take Everolimus medac once a day, about the same time each day, regularly with or without
food.
Swallow the tablet(s) whole with a glass of water. Do not chew or crush the tablets.

If you take more Everolimus medac than you should

• If you have taken more Everolimus medac than you should, or if someone else has accidentally taken your tablets, contact a doctor immediately or go to hospital. Emergency treatment may be necessary.

If you forget to take Everolimus medac
If you forget to take a dose, take the next dose as scheduled. Do not take a double
dose to make up for forgotten tablets.

If you stop taking Everolimus medac
Do not stop treatment with Everolimus medac unless your doctor tells you to do so.
If you have any questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
STOP treatment with Everolimus medac and seek immediate medical attention if you experience any of the
following signs of an allergic reaction:

• difficulty breathing or swallowing
• swelling of the face, lips, tongue or throat
• severe itching of the skin, with a red rash or skin swellings

Serious side effects of Everolimus medac include:
Very common(may affect more than 1 in 10 people)

• Increased temperature, chills (signs of infection)
• Fever, cough, difficulty breathing, wheezing (signs of lung inflammation, also known as pneumonia) Common(may affect up to 1 in 10 people)
• Excessive thirst, high urine output, increased appetite with weight loss, fatigue (signs of diabetes)
• Bleeding (haemorrhage), for example in the intestinal wall
• Severe decrease in urine production (signs of kidney failure)

Uncommon(may affect up to 1 in 100 people)

• Fever, rash, pain and inflammation of the joints, as well as fatigue, loss of appetite, nausea, jaundice (yellowing of the skin), pain in the upper right side of the abdomen, pale stools, dark urine (may be signs of hepatitis B reactivation)
• Shortness of breath, difficulty breathing when lying down, swelling of the feet and legs (signs of heart failure)
• Swelling and/or pain in one of the legs, usually in the calf, redness or warmth of the skin in the affected area (signs of a blocked blood vessel (vein) in the legs caused by blood clotting)
• Sudden onset of shortness of breath, chest pain or coughing up blood (potential signs of pulmonary embolism, a condition that occurs when one or more arteries in the lungs become blocked)
• Severe decrease in urine production, swelling of the legs, feeling confused, back pain (signs of sudden kidney failure)
• Rash, itching, hives, difficulty breathing or swallowing, dizziness (signs of severe allergic reactions, also known as hypersensitivity) Rare(may affect up to 1 in 1,000 people)
• Shortness of breath or rapid breathing (signs of acute respiratory distress syndrome)

If any of these side effects occur, tell your doctor immediately, as this could be life-threatening.
Other possible side effects of Everolimus medac include:
Very common(may affect more than 1 in 10 people)

• High blood sugar levels (hyperglycaemia)
• Loss of appetite
• Altered sense of taste (dysgeusia)
• Headache
• Nosebleeds (epistaxis)
• Cough
• Mouth ulcers
• Stomach problems including feeling unwell (nausea) or diarrhoea
• Rash
• Itching
• Fatigue or weakness
• Fatigue, shortness of breath, dizziness, paleness (signs of low red blood cell count (anaemia))
• Swelling of the arms, hands, feet, ankles or other parts of the body (signs of oedema)
• Weight loss
• High levels of lipids (fats) in the blood (hypercholesterolaemia)

Common(may affect up to 1 in 10 people)

• Spontaneous bleeding or bruising (signs of a low platelet count, also known as thrombocytopenia)
• Shortness of breath (dyspnoea)
• Thirst, low urine output, dark urine, dry and flushed skin, irritability (signs of dehydration)
• Difficulty sleeping (insomnia)
• Headache, dizziness (signs of high blood pressure, also known as hypertension)
• Fever, sore throat, mouth ulcers caused by infections (signs of a low white blood cell count, leucopenia, lymphopenia and/or neutropenia)
• Fever
• Inflammation of the lining of the mouth, stomach and intestines
• Dry mouth
• Heartburn (dyspepsia)
• Feeling sick (vomiting)
• Difficulty swallowing (dysphagia)
• Abdominal pain
• Acne
• Rash and pain on the palms of the hands or soles of the feet (hand-foot syndrome)
• Redness of the skin (erythema)
• Joint pain
• Pain in the mouth
• Menstrual disorders such as irregular periods
• High levels of lipids (fats) in the blood (hyperlipidaemia, increased triglycerides)
• Low potassium levels in the blood (hypokalaemia)
• Low phosphate levels in the blood (hypophosphataemia)
• Low calcium levels in the blood (hypocalcaemia)
• Dry, flaky and damaged skin
• Nail problems, brittle nails
• Mild hair loss
• Altered results in blood tests for liver function (increased alanine and aspartate aminotransferases)
• Altered results in blood tests for kidney function (increased creatinine)
• Eye discharge with itching, redness and swelling
• Protein in the urine

Uncommon( may affect up to 1 in 100 people)

• Weakness, spontaneous bleeding or bruising and frequent infections with signs such as fever, chills, sore throat or mouth ulcers (signs of a low level of blood cells, also known as pancytopenia)
• Loss of taste (ageusia)
• Coughing up blood (haemoptysis)
• Menstrual disorders such as absence of periods (amenorrhoea)
• Need to urinate more often during the day
• Chest pain
• Problems with wound healing
• Hot flushes
• Red eyes (conjunctivitis)

Rare(may affect up to 1 in 1000)

• Fatigue, shortness of breath, dizziness, paleness (signs of a low level of red blood cells in the blood, possibly due to a type of anaemia called pure red cell aplasia)
• Swelling of the face, around the eyes, mouth and inside the mouth and/or throat, as well as the tongue and difficulty breathing or swallowing (also known as angioedema), may be signs of an allergic reaction

If these side effects worsen tell your doctor and/or pharmacist. Most side effects are mild or moderate and usually disappear if the treatment is stopped for a few days.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-
avverse . By reporting side effects you can help provide more information on the safety of this medicine

5. How to store Everolimus medac

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and blister after Exp.. The
expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
Only open the blister when you are ready to take the tablets.
Do not use this medicine if you notice that the packaging is damaged or tampered with.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Everolimus medac contains

• The active ingredient is everolimus. Each Everolimus medac 5 mg tablet contains 5 mg everolimus. Each Everolimus medac 10 mg tablet contains 10 mg everolimus.
• The other ingredients are: butylhydroxytoluene (E 321), hypromellose 3 cPs, lactose monohydrate, anhydrous lactose, crospovidone type A, magnesium stearate

Description of the appearance of Everolimus medac and contents of the pack
Everolimus medac 5 mg tablets are white, oblong, flat tablets with rounded corners
engraved with “EV” on one side and “5” on the other.
Everolimus medac 10 mg tablets are white, oblong, flat tablets with rounded corners
engraved with “EV” on one side and “10” on the other.
Everolimus medac 5 mg and Everolimus medac 10 mg are available in packs containing 30 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
medac pharma s.r.l
Via Viggiano 90
00178 Rome
Italy

Manufacturer
TEVA Gyógyszergyár Zrt., Pallagi út 13, Debrecen 4042, Hungary
PLIVA Croatia Ltd., Prilaz baruna Filipovica 25, 10000, Zagreb, Croatia